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studies? Who should decide what criteria to use to define a favorable risk-benefit ratio?

To determine when a risk-benefit ratio is favorable or unfavorable requires a standard of evaluation, and one appropriate for patients with advanced cancer whose health will most likely deteriorate and who will die, yet no standard has been explicitly articulated. Indeed, determining risk-benefit ratios is one of the most important, but least developed, areas of determining the ethics of research trials.2,77-79 One approach could be to elucidate a standard based on socially accepted determinations of risk-benefit ratios already used for cancer treatments, such as in FDA approval of cancer agents. For example, high-dose interleukin 2 (IL-2) is the only FDA-approved treatment for metastatic renal cell carcinoma. This IL-2 regimen has a response rate of 14% (5% complete responses, 9% partial responses), with a median response duration of 20 months.80 The possible toxicities of IL-2 are substantial, including a sepsis-like syndrome, requiring judicious use of fluids and vasopressor support to maintain blood pressure while avoiding pulmonary edema from capillary leak. Other chemotherapy treatments, such as gemcitabine, are the FDA-approved treatment of choice for metastatic pancreatic cancer, despite a 5.4% response rate, because of demonstrated quality of life benefits.81 Thus, an explicit standard, or at least a reasonable approach by which to judge a risk-benefit ratio of Phase I studies, is needed to meaningfully discuss whether a particular risk-benefit ratio is favorable or unfavorable.

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